A licensee shall meet the following requirements for determination of dosages of unsealed byproduct material:

1. (a) A licensee shall determine and record the activity of each dosage prior to medical use;

2. (b) For a unit dosage, this determination shall be made by:

   1. (1) Direct measurement of radioactivity; or

   2. (2) A decay correction, based on the activity or activity concentration determined by:

      1. a. A manufacturer or preparer licensed under He-P 4032.05, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission;
      2. b. A DHHS/RHS, or an agreement state or a Nuclear Regulatory Commission licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
      3. c. A PET radioactive drug producer licensed under He-P 4032.05, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission;

3. (c) For other than unit dosages, this determination shall be made by:

   1. (1) Direct measurement of radioactivity; and either
   2. (2) Combination of measurement of radioactivity and mathematical calculations; or

   3. (3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

      1. a. A manufacturer or preparer licensed under He-P 4032.05, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or
      2. b. A PET radioactive drug producer licensed under He-P 4032.05, the equivalent requirements of an agreement state, or Nuclear Regulatory Commission;
4. (d) Unless otherwise directed by the authorized user, a licensee shall not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent; and

5. (e) A licensee shall retain a record of the dosage determination required by He-P 4035.19 for 3 years. The record shall include:

   1. (1) The radiopharmaceutical;
   2. (2) The patient’s or human research subject’s name, or identification number if one has been assigned;
   3. (3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 megabecquerels (30 microcuries);
   4. (4) The date and time of the dosage determination; and
   5. (5) The name of the individual who determined the dosage.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07 New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22